EPA’s unwritten policy on chemical data: don’t ask, don’t tell

There are almost 40,000 chemicals in commerce, and EPA needs to take action to limit those that are dangerous. That’s why the reformed Toxic Substances Control Act (TSCA) directs EPA to select (through a prioritization process as shown below) 20 “high-priority,” potentially risky chemicals by the end of next year for assessment. To make informed choices, EPA needs data on how these chemicals might impact health—but based on their recent prioritization plan, it appears the Agency has no intention of using its new TSCA authorities to get data from industry.

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The prioritization process evaluates a subset of the chemicals in commerce to select those that are high priority for risk evaluation, and those that are low priority (unlikely to be dangerous). A high priority designation blocks most actions by states.

EPA’s prioritization plan describes how it will choose high priority chemicals—and for chemicals with insufficient data, the plan weakly offers that EPA “may” provide public notification of data deficiencies. ‘May’ give some notification is a long way from getting actual data on health risks which we badly need—not much has changed since 1998 when 43% of high production volume chemicals (produced at over a million pounds a year) had no available data on human health hazards. This is exactly why Congress expressly amended TSCA to give EPA authorities to request data and fill these large gaps.

Yet, EPA has not issued a single test order in the 2 years since Congress amended TSCA. In comments to the Agency, leading researchers and health professionals strongly recommended that it should use its full authorities to gather existing data from companies, issue test orders to generate new data, and make this data available to the public.

Filling data gaps is critical to make decisions about high priority chemicals, and on the flip side for “low-priority” chemicals as well. Low priority chemicals are those deemed unlikely to be dangerous after a comprehensive evaluation, and thus receive no further evaluation and are essentially declared “safe.” EPA also has to designate 20 low priority chemicals by the end of 2019.

To make this designation, EPA must have sufficient and thorough information on a chemical and its health effects, including for sensitive subpopulations like pregnant women and children. This encompasses whether it is a carcinogen, an endocrine disruptor, harmful to development, or has a host of other health hazards. One example of a current best practice in this regard is the GreenScreen for safer chemicals, which assesses the comprehensive suite of health hazard endpoints shown below in its chemical evaluation process.

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To evaluate chemicals, GreenScreen requires information on key health hazards, including single and repeated dose toxicity for several endpoints. Source: Clean Production Action, Green Screen Overview

EPA also needs information on a chemical’s uses and exposures. As for high priority chemicals, EPA should use its TSCA authorities to issue orders for the needed data, such as testing for all the endpoints above and monitoring for the chemical in the air, water or people.

Because a low priority designation means a chemical is on a fast-track exit ramp from regulation, industry has shown special interest in getting this label for chemicals. EPA’s prioritization plan proposes an “enhanced stakeholder role” in low priority designations, raising serious concerns about industry’s growing role and influence in the decision-making process.

As experience with many chemicals has shown, financial conflicts of interest can lead to biased science and poor decisions that leave the public at risk. A recent article from Markowitz and Rosner describes the decades of industry manipulation and deception around the science of PCBs (polychlorinated biphenyls) which led to the current situation of global contamination, ubiquitous exposure and numerous diseases linked to these toxic chemicals.

To avoid repeating such disasters, protect the public, and meet the requirements of the law, EPA must obtain sufficient data sets on chemicals through orders and work to remove– not enhance–undue industry influence on its science and decisions. The reality is that until industry fulfills its responsibilities to only market safer chemicals, and EPA holds them accountable to this, the public will bear the burden of chemicals that may be harming their health.